- The U.S. Food and Drug Administration (FDA) has given its approval to several first generics of the renowned ADHD medication Vyvanse.
- This announcement comes at a crucial time when the manufacturer of Vyvanse has been grappling with surging demand and associated delays.
- Experts assert that the availability of generic versions will not only diversify treatment options for patients but also potentially contribute to cost reduction.
- Pharmaceutical companies based in the United States, the United Kingdom, and India have swiftly taken action, commencing the distribution of their respective generic iterations of Vyvanse.
In June 2023, Takeda, the Japanese manufacturer behind the ADHD medication Vyvanse (lisdexamfetamine dimesylate), issued a statement acknowledging low inventory due to manufacturing delays and increased demand. However, on August 28, 2023, the U.S. Food and Drug Administration (FDA) shared potentially good news for those affected by the shortage, announcing the approval of several first generic
These “first generics” signify the FDA’s initial approvals for the production of generic versions of Vyvanse. These generics will be available in both capsule and chewable tablet forms, catering to the treatment of moderate-to-severe binge-eating disorder (BED) in adults and attention-deficit/hyperactivity disorder (ADHD) in children aged 6 and older.
BED ranks as the most prevalent eating disorder in the U.S., as noted by the National Eating Disorders Association. Individuals with BED experience recurring episodes of excessive food consumption, often feeling a sense of loss of control during these episodes.
ADHD, on the other hand, is a common neurodevelopmental disorder typically diagnosed during childhood, although it frequently persists into adulthood. The U.S. Centers for Disease Control and Prevention highlight its hallmark symptoms, including inattention, impulsivity, and hyperactivity.
What Generic Vyvanse Means for Patients
Dr. Stefan Ivantu, a private psychiatrist specializing in adult ADHD and complex cases in London, England, emphasized the significance of this announcement. He stated, “This announcement is highly important since the supply chains will become more robust, considering the pandemic period and increased demand for prescribing.”
Ivantu further explained that having access to generic medications is crucial when supply chains face challenges, providing patients and prescribers with additional options. He added, “This announcement develops redundancies within a system that is continuously growing and under pressure,” also noting that increased competition could potentially lower costs for patients.
Dr. Nicole Garber, chief medical officer with Alsana, a national eating disorder treatment program, pointed out the particular benefit for individuals with binge-eating disorders. “While several other medications are approved for the treatment of ADHD, Vyvanse is the only medication approved for the treatment of binge-eating disorder,” she emphasized.
Garber highlighted that cognitive behavioral therapy, the gold-standard treatment for binge-eating disorder, aims to modify behavior by helping individuals recognize unhelpful thought patterns. Additionally, nutritional therapy can assist individuals in returning to healthy eating patterns. Medications like Vyvanse can complement these approaches to managing symptoms, although Garber emphasized that they should be part of a comprehensive treatment program.
Timeline for Availability of Generic Vyvanse
Generic drugs typically become available after the expiration of their patents. Dr. Praveen Guntipalli, Medical Director and Owner of Sanjiva Medical Spa in Dallas, Texas, noted that Vyvanse’s patent officially expired on February 24, 2023. However, Takeda maintained market exclusivity through August 24, 2023, due to pediatric exclusivity.
Ivantu clarified that the availability of generic versions might not be immediate. Delays can occur due to the complexity of quality checks and distribution processes within generic drug manufacturers. The timeline for availability can vary, taking months or even years, depending on preparedness and location.
According to reports by Reuters, pharmaceutical companies in the U.S. (Mallinckrodt and Viatris), the UK (Hikma Pharmaceuticals), and India (Sun Pharmaceutical Industries) have confirmed shipping their respective versions of the drug.
Ivantu recommends staying informed about generic drug availability by consulting a healthcare professional, although he anticipates availability by year’s end.
In the interim, Takeda anticipates the shortage of its brand-name drug to persist through September.
The Bottom Line
With Takeda’s Vyvanse patent recently expiring, the door is now open for generic lisdexamfetamine dimesylate to enter the market. This medication is commonly used to treat moderate-to-severe binge-eating disorder in adults and ADHD in children aged 6 and older. Generics offer more options for patients and can potentially reduce prices. Pharmaceutical companies in the U.S., UK, and India have already begun shipping generic versions of Vyvanse. Healthcare professionals can provide specific details on patient availability. The shortage of the brand-name drug is expected to continue into September.